Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care

HIV Testing Clinical Trial

— MAS  

Official title:

Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939455
• Other study ID #: Moile Augmented Screening
• Status: Completed
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: May 2021
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Because adolescents and young adults face markedly increased HIV risk yet frequently do not test, we propose to complete the Mobile Augmented Screening (MAS) tool designed to increase HIV testing, and to facilitate linkage to care and ongoing prevention education. This tool will help clinicians address undiagnosed youth HIV, and enable young patients to receive much needed treatment and avoid unknowingly transmitting infection. Our product is designed to help existing program staff reach an increased number of clients; and to improve public health by encouraging reluctant young patients to accept important HIV testing and care they may otherwise decline.

Description:

Our randomized trial will evaluate HIV test rates among participants who complete a tablet-based intervention, the Mobile Augmented Screening tool (MAS), compared to participants in a treatment as usual (TAU) condition.

Research staff will approach 350 emergency department (ED) patients aged 13 - 24 years. Participants will be randomized into the intervention or TAU condition. Participants will be randomized in a 1:1 ratio to the intervention or TAU condition, stratified by patient age (13-17 and 18-24). Within each of these age strata, permuted blocks randomization with varying block sizes will be employed to ensure balance and concealment of allocations prior to randomization.

Participants who are randomized into the intervention condition will watch a 5-minute video on a tablet computer, and the tablet will ask intervention participants if they would like an HIV test. Possible responses will be "Yes" or "No". Participants who are randomized into TAU will be offered HIV tests by research staff. All participants in both conditions who agree to HIV testing will be tested by hospital staff in the location where they are receiving treatment. All participants who test will receive their results in person from ED staff before discharge.

The primary trial outcome will be percentages of patients, by treatment group, who test for HIV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: June 1, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 24 Years

Eligibility

Inclusion Criteria:

Emergency Department patients aged 13 - 24 years will be eligible for the study if they are:

• awake

• able to provide consent as determined by ED staff

• understand written and spoken English

• not intoxicated

• not known to be HIV positive

• not a prisoner

• have not already agreed to test for HIV during their current ED visit (this will include patients who decline HIV testing offered by hospital staff and patients who are not yet offered HIV testing; potential differences in test rates among participants who decline vs. those who have not previously been offered an HIV test will be explored as a secondary outcome)

Exclusion Criteria:

Exclusion criteria include patients who are prisoners, patients who are asleep/unconscious, unable to provide consent as determined by ED staff, do not understand written and spoken English, are intoxicated, are known to be HIV positive, have already agreed to an HIV test during their current ED visit, have been categorized by ED staff as altered mental status or are presenting to the ED for a psychiatric problem. Additionally, the proposed research will exclude patients if medical records indicate hospital staff have categorized the patient as most urgently in need of medical care.

Related Conditions & MeSH terms

• HIV Testing

Intervention

Other:
• Mobile Augmented Screening tool
Tablet-based intervention

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV testing	The main outcome is participant HIV testing. We will measure whether the participant accepts an HIV test when offered. Possible outcomes are Yes or No.	Day of study participation.